Study On The Compound Luotuopengzi Hydrogel Patch

Objective: To study a new hydrogel patch from Compound Luotuopengzi ointment which was developped from the prescription of Xinjiang Uygur traditional medicines, to carry on the study of its formulation and quality control method and compare Compound Luotuopengzi ointment and hydrogel patch’s transdermal’s performance of their release and stability, lay the foundation for the hydrogel patch’s further research. Method:(1)Using single factor experiment to screen the type of hydrogel patch’s cross-linking agent, cross-linking modifier, humectants and tackifier; using Franz vertical diffusion cell method to screen the type of penetration enhancer; with the preliminary review and hold tack evaluation as indexs, carry on orthogonal test optimize prescription to determine the optimal formulation process.(2)Using the TLC method to simultaneously distinguish the six components in the Compound Luotuopengzi hydrogel patch; using the HPLC method to determine the harmaline, harmine, vasicine and colchicine’s contents in Compound Luotuopengzi hydrogel patch, and carry on adhesion, the weight difference, the heat, and cold forming and other tests.(3)Using Franz vertical diffusion cell method to carry on in vitro percutaneous absorption test of Compound Luotuopengzi hydrogel patch and ointment, draw different times transdermal drug penetration curves,calculate and compare basis cumulative penetration amount Q, through multiple Er and permeation rate constants J; using the paddle method, HPLC analysis in vitro release of ointments and hydrogel patch, draw release profile and compare the release property.(4)To study the preliminary stability of the hydrogel patch, and carry on impact factor test, accelerated test and long-term test, and compare with the ointment. Results:(1)Through single factor and orthogonal experiment to determine the optimal formulation is: NP700 5 g, Gan hydroxyl aluminum 0.4 g, tartaric acid 0.4 g, glycerin 50 g, PVPK-30 2 g, water 35.95 g, propylene glycol, azone 2.5 g+2.5 g, extract1.25 g, total prescription 100 g, can coat 50cm2,shaped hydrogel patch with bright color, uniform matrix good adhesion.(2)With the harmaline, harmine, vasicine, colchicine, scopolamine hydrobromide and atropine sulfate as indicators effectively establish the active ingredients qualitative identification TLC method of the Compound Luotuopengzi hydrogel patch; with the harmaline, harmine, vasicine and colchicine as indexs establish the HPLC method can quickly determine the alkaloids active ingredient of the hydrogel patch, method science study shows that the average recovery of the four component’s precision, stability and reproducibility’s RSD values less than 2%, other tests shows that the patch’s adhesion, heat, cold, forming property are good, the weight difference is small.(3)Transdermal performance test, the harmaline and harmine in the hydrogel patch’s Q, Er and J are more than ointment;release performance test, ointment and hydrogel patch’s harmaline and harmine are both use 10 hours to reach maximum release, patch’s release rate more than ointment.(4)Factors experiment result shows that high temperature and humidity are factors that significantly affect dosage traits, high temperature is a significant factor to change the active ingredient content, but the light cream has little effect on active ingredient content and formulation traits in hydrogel patch and ointment; accelerated test, the hydrogel patch’s 2,3 and 6 months harmaline requirement changes exceed content limit, content changes of the harmaline, harmine, vasicine and colchicine in two formulations are conform the limited requirements, dosage trait is also stable; the long-term test, the ointment and hydrogel patch’s main active ingredient content and dosage trait both are stable Conclusion:shaped hydrogel patch formulation process is stability, establish the qualitative and quantitative methods are accurate, reasonable, feasible, stable and simple, laid the foundation for establishing quality standards of the Compound Luotuopengzi hydrogel patch;hydrogel patch’s transdermal stickers agent and emission performance are better than ointment, induct that use ointment develop to the hydrogel patch, not only to improve the ointment paste thick black greasy, inconvenient, poor uniformity and other shortcomings, but also improve the fundamental quality and exert better pharmacodynamics.